Method and Apparatus for Retention of Adipose Tissue

ABSTRACT

A tissue retention system to assist in maintaining adipose tissue on a patient in a displaced position during a medical procedure to provide access to a body region of the patient includes an anchor pad having a pad length and a pad width. The anchor pad may include a pad body with an adhesive surface thereon, the adhesive being configured to adhere to a patient&#39;s skin. The anchor pad also may include an opposing first attachment surface facing away from the adhesive surface. The tissue retention system also may include a tension member having a second attachment surface.

PRIORITY DATA

This application is a continuation of U.S. patent application Ser. No.15/230,101, filed Aug. 5, 2016, which is a continuation of U.S. patentapplication Ser. No. 14/853,549, filed Sep. 14, 2015, now U.S. Pat. No.9,408,741, which is a continuation of U.S. patent application Ser. No.14/470,341, filed Aug. 27, 2014, now U.S. Pat. No. 9,144,423, which is acontinuation of U.S. patent application Ser. No. 13/727,145, filed Dec.26, 2012, now U.S. Pat. No. 8,881,732, which is a divisional of U.S.patent application Ser. No. 12/106,821, filed Apr. 21, 2008, which isabandoned, all of which are incorporated herein by reference in theirentirety.

TECHNICAL FIELD

This disclosure relates in general to a method and system for retentionof tissue in a variety of applications and retaining objects in relationto tissue. More particularly, in some particular embodiments thisdisclosure relates to methods and systems for retention of adiposetissue and maintaining it in a displaced position during a medicalprocedure on a patient.

BACKGROUND

The size and constitution of the human body can affect the availabilityand efficiency of medical care that can be provided. For example,adipose tissue, such as a pannus or an abdominal apron on an obesepatient, may completely obscure access to a body region requiring amedical procedure. In cases of excessive adipose tissue, a treatingmedical professional attempting to examine, treat or otherwise accessthe lower abdomen or groin region of the patient may have only limitedvisualization and may have insufficient access to perform procedures.

Current systems and methods for dealing with adipose tissue, such as thepannus, are inadequate. These may include having medical staff use theirhands to hold the weight of the pannus or other adipose body tissueduring the entire procedure, may include using tape (or tape inconjunction with spray adhesives) to hold the pannus or other adiposetissue, may include using hooks that secure or grab the pannus or otheradipose tissue, and may include supporting the pannus or adipose tissuewith a sheet that may be tied around the patient's abdomen and to a bedside rail or chair. These all have shortcomings that continue to makemedical procedures difficult.

The present disclosure overcomes one or more shortcomings in the art.

SUMMARY

In one exemplary aspect, the present disclosure is directed to a tissueretention system to assist in maintaining adipose tissue on a patient ina displaced position during a medical procedure to provide access to abody region of the patient. The tissue retention system comprises aflexible anchor pad having an anchor pad width and an anchor pad length.The anchor pad also has an anchor pad area defined at least partially bythe width and length. The anchor pad comprises a pad body with anadhesive surface thereon, the adhesive being configured to selectivelyadhere to a patient's skin. It also comprises an opposing firstattachment surface facing away from the adhesive surface. In oneembodiment, the first attachment surface includes one of a hook and loopportion of a hook and loop fastener. The tissue retention system alsocomprises a flexible tension member having a distal portion and aproximal portion. The flexible tension member has a second attachmentsurface disposed adjacent the distal portion. In some embodiments, thesecond attachment surface includes the other of the hook and loopportion of a hook and loop fastener. In one embodiment, the tensionmember has a tension member width less than the anchor pad width andless than the anchor pad length. The flexible tension member is sized tocooperate with the anchor pad to define an overlap area less than thesize of the anchor pad area, such that loading onto the anchor pad fromthe tension member is distributed over an area of the skin greater thanthe area of the overlap of the first and second attachment surfaces.

In another exemplary aspect, the tissue retention system includes aflexible anchor pad having a first attachment surface including one of ahook and loop portion of a hook and loop fastener. The system alsoincludes a flexible tension member having a second attachment surfaceincluding the other of the hook and loop portion of a hook and loopfastener. The hook and loop fastener of the first and second attachmentsurfaces having a 135 degree closure peel strength within the range ofabout 1-10 oz/inch width.

In another exemplary aspect, the tissue retention system includes aflexible anchor pad and a flexible tension member wherein the flexibletension member has elongation properties and the adhesive of the anchormember has adhesive properties when attached to a patient's skin, suchthat when the first and second attachment surfaces are fastened, thetension member elongates under tension loads before the adhesive on theanchor pad damages the patient's skin.

In another exemplary aspect, the present disclosure is directed to a kitfor maintaining adipose tissue on a patient in a displaced positionduring a medical procedure to provide access to a body region of thepatient. In one embodiment, the includes the tissue retention system. Insome embodiments, the kit includes a plurality of flexible anchor padsand at least one flexible tension member.

In another exemplary aspect, the present disclosure is directed to amethod of maintaining adipose tissue on a patient in a displacedposition during a medical procedure to provide access to a body portionof the patient with a tissue retention system. The method includesadhesively adhering directly to a patient's skin adjacent the adiposetissue an adhesive surface of an anchor pad, the anchor pad having a padlength and a pad width, the anchor pad having an opposing firstselective attachment surface facing away from the adhesive surface, thefirst selective attachment surface including a hook portion of a hookand loop fastener. The method also includes attaching a first portion ofa tension member having a second selective attachment surface to thefirst selective attachment surface of the anchor pad, the secondselective attachment surface includes the loop portion of the hook andloop fastener. The method also includes displacing adipose tissue from anatural position to a displaced position and maintaining the adiposetissue in the displaced position with the tension member.

In another exemplary aspect, the present disclosure is directed to amethod of maintaining a pannus on a patient in a displaced positionduring a medical procedure to provide access to a body region of thepatient with a tissue retention system. The method includes adhesivelyadhering directly to a patient's abdomen an adhesive surface of a firstanchor pad, the first anchor pad having a pad length and a pad width,the first anchor pad having an opposing first selective attachmentsurface facing away from the adhesive surface. The method also includesadhesively adhering a second anchor pad at an anchoring location spacedfrom the first anchor pad and includes attaching a first portion of atension member having a second selective attachment surface to the firstselective attachment surface of the anchor pad without adhesivelyadhering the tension member directly to the patient's skin. Adiposetissue on the abdomen is displaced from a natural position to adisplaced position. A second portion of the tension member is attachedto the second anchor pad so that the tension member is in tensionbetween the first and the second anchor pads. The adipose tissue ismaintained in the displaced position with the tension member.

In another exemplary aspect, the present disclosure is directed to amethod of maintaining adipose tissue on a thigh of a patient in adisplaced position during a medical procedure.

In another exemplary aspect, the present disclosure is directed to amethod of maintaining a breast on a patient in a displaced positionduring a medical procedure to provide access to a body region of thepatient with a tissue retention system.

In another exemplary aspect, the present disclosure is directed to amethod of maintaining buttocks on a patient in a displaced positionduring a medical procedure to provide access to a body region of thepatient with a tissue retention system.

In another exemplary aspect, the present disclosure is directed to amethod of maintaining adipose tissue on a patient in a displacedposition with a tissue retention system during a child birthingprocedure to provide access to the abdominal region of the patient. Themethod includes scrubbing the abdomen with a cleanser and removing abacking from a flexible anchor pad to expose an adhesive surface of theanchor pad, the anchor pad having an opposing first attachment surfacefacing away from the adhesive surface. The method includes adhesivelyadhering directly to the patient's lower abdomen the adhesive surface ofthe anchor pad. It should be noted that the in some instances, thepannus can be scrubbed or prepped directly through the porous anchorpads after the anchor pads are in place. A first portion of a tensionmember having a second selective attachment surface is attached to thefirst selective attachment surface of the anchor pad. Adipose tissue isdisplaced from a natural position to a displaced position using thesupport member to pull the anchor pad and abdomen. The adipose tissue ismaintained in the displaced position with the tension member.

In another exemplary aspect, the present disclosure is directed to amethod of maintaining adipose tissue on a patient in a displacedposition with a tissue retention system during a femoral catheterizationprocedure to provide access to the femoral region of the patient. Themethod includes adhesively adhering directly to a patient's skinadjacent the adipose tissue an adhesive surface of an anchor pad, theanchor pad having an opposing first attachment surface facing away fromthe adhesive surface. A first end of a tension member having a secondselective attachment surface is attached to the first selectiveattachment surface of the anchor pad. Adipose tissue is displaced from anatural position to a displaced position, and the adipose tissue ismaintained in the displaced position with the tension member. A portionof the femoral region of the patient is cleansed and a needle isintroduced through the cleansed portion of the femoral region of thepatient.

In another exemplary aspect, the present disclosure is directed to amethod of applying pressure to a femoral artery on a patient after afemoral catheterization procedure. The method includes the steps ofadhesively adhering directly to a patient's skin adjacent tissue on apatient's thigh an adhesive surface of an anchor pad. The anchor pad hasan opposing first selective attachment surface facing away from theadhesive surface. The method also includes attaching a first end of atension member having a second selective attachment surface to the firstselective attachment surface of the anchor pad. A force is appliedthrough the tension member to cause pressure to be applied to theincision in the femoral region of the patient. In a further aspect asterile pad may be placed over the incision to control bleeding and/orintensify the pressure on the incision. Further, a second anchor pad maybe applied and the tension member will be attached to the second pad tomaintain the applied tension.

In another exemplary aspect, the present disclosure is directed to a kitfor performing a catheterization procedure on a patient having an excessof adipose tissue in an abdominal region of the patient. The kitincludes a needle sized to puncture the patient's skin, a flexiblehollow tube for threading through the femoral artery, and a flexibleanchor pad having a length and width. The anchor pad includes a pad bodywith an adhesive surface thereon, the adhesive being configured toselectively adhere to a patient's skin adjacent the adipose tissue. Italso includes an opposing first attachment surface facing away from theadhesive surface, the first attachment surface including one of a hookand loop portion of a hook and loop fastener. The kit includes aflexible tension member having a second attachment surface, the secondattachment surface including the other of the hook and loop portion of ahook and loop fastener, the tension member having a width less than thewidth and less than the length of the anchor pad such that loading ontothe anchor pad from the support member is distributed over an area ofthe skin greater than the area of the overlap of the first and secondattachment surfaces.

In another exemplary aspect, the present disclosure is directed to a kitfor a medical professional performing a medical procedure. It includes acotton tip applicator, pads, gauze, suction tubing, and a Foleycatheter. It also includes a plurality of anchor pads each having a padlength and a pad width. Each anchor pad includes a pad body with anadhesive surface thereon, the adhesive being configured to selectivelyadhere to a patient's skin, and includes an opposing first attachmentsurface facing away from the adhesive surface, the first attachmentsurface including hook portion of a hook and loop fastener. The kit alsoincludes a tension member having a second attachment surface, the secondattachment surface including a loop portion of a hook and loop fastener.The tension member has a tension member width less than the pad widthand less than the pad length of the anchor pad such that loading ontothe anchor pad from the support member is distributed over an area ofthe skin greater than the area of the overlap of the first and secondattachment surfaces.

In another exemplary aspect, the present disclosure is directed to atissue retention system to assist in maintaining adipose tissue on apatient in a displaced position during a medical procedure. The tissueretention system includes a flexible anchor pad having a pad length anda pad width. The anchor pad includes a pad body with an adhesivethereon, the adhesive being configured to selectively adhere to apatient's skin and includes an opposing first attachment surface facingaway from the adhesive surface. The system also includes a flexibletension member having a second attachment surface configured toselectively attach to the first attachment surface.

In another exemplary aspect, the present disclosure is directed to amethod of maintaining adipose tissue on a patient in a displacedposition during a medical procedure to provide access to a body portionof the patient with a tissue retention system. The method may includeadhesively adhering directly to a patient's skin at a displacement sitean adhesive surface of an anchor pad, the anchor pad having an opposingfirst selective attachment surface facing away from the adhesivesurface. A first portion of a tension member having a second selectiveattachment surface is attached to the first selective attachment surfaceof the anchor pad without adhesively adhering the tension memberdirectly to the patient's skin. Adipose tissue is displaced from anatural position to a displaced position, and the adipose tissue ismaintained in the displaced position with the tension member. In afurther aspect, the displacement site on the skin includes a firstanchor pad and the retention system includes at least two additionalanchor pads. In this embodiment, a first tension member is releasablyattached to the first anchor pad and is releasably connected to a secondanchor pad spaced from the displacement site. A second tension member isreleasably connected to the first anchor pad and is releasably connectedto a third anchor pad spaced from the displacement site and the secondanchor pad. The first tension member extends in a first direction andthe second tension member extends in a second direction such that thedisplacement site can be displaced at in least in part in both the firstand second directions.

Further aspects, forms, embodiments, objects, features, benefits, andadvantages of the present invention shall become apparent from thedetailed drawings and descriptions provided herein.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1a and 1b are illustrations of an exemplary tissue retentionsystem according to one embodiment of the present invention.

FIG. 2 is an illustration of an obese patient showing the pannus orabdominal apron with attached anchor pads of the exemplary tissueretention system.

FIGS. 3a-3c are illustrations of an application of the exemplary tissueretention system to maintain the pannus in a displaced position.

FIG. 4 is an illustration showing an alternative method of maintainingthe pannus in a displaced position with the tissue retention system byattaching the tissue retention system to an operating table.

FIG. 5 is an illustration showing an exemplary application of the tissueretention system to maintain breast tissue of a patient in a displacedposition.

FIG. 6 is an illustration showing an exemplary application of the tissueretention system to maintain thigh tissue of a patient in a displacedposition.

FIG. 7 is an illustration showing an exemplary application of the tissueretention system to maintain the buttocks of a patient in a displacedposition.

FIGS. 8-10 are illustrations showing an exemplary application of thetissue retention system to maintain adipose tissue of a patient in adisplaced position.

FIG. 11 is an illustration showing exemplary directional loading ofcomponents of the tissue retention system.

FIG. 12 is an illustration showing an exemplary kit having components ofthe tissue retention system.

DETAILED DESCRIPTION

For the purposes of promoting an understanding of the principles of theinvention, reference will now be made to the embodiments, or examples,illustrated in the drawings and specific language will be used todescribe the same. It will nevertheless be understood that no limitationof the scope of the invention is thereby intended. Any alterations andfurther modifications in the described embodiments, and any furtherapplications of the principles of the invention as described herein arecontemplated as would normally occur to one skilled in the art to whichthe invention relates.

Adipose tissue may hinder treatment during other routine or non-routinetreatment. For example, in some instances, adipose tissue maydetrimentally affect visualization or other access to performprocedures, such as, for example, panniculectomys, to treatpanniculitis, general wound care, femoral catheterization, trachealintubation, cesarean sections, hysterectomies, among other medicalprocedures.

The tissue retention system disclosed herein maintains adipose tissue ina position that provides better access to patient body regions requiringtreatment. For example, it may be used to displace or secure adiposetissue, such as the abdominal apron or pannus, out of the lower abdomenor groin region during child birthing to provide better visualizationand easier access to an attending health care provider.

Skin is composed of multiple layers. The main layers comprise theepidermis layer, the dermis layer, and subcutaneous tissue. Theepidermis layer comprises sublayers including stratum corneum, stratumludidum (not present in thin skin, only thick, hairless skin of palms &soles), stratum granulosum, stratum spinosum, and stratum germinativum.The tissue retention system disclosed herein is a non-penetratingsolution that adheres to the epidermal layers of the skin withoutadhering to the dermis or subcutaneous tissue to displace adipose tissuewhile maintaining skin integrity. Further, certain aspects do so withoutpenetrating or pinching tissue to obtain skin anchorage, unlike hooks orother skin gripping systems, which can damage the skin. Instead, it isflexible enough to conform to natural curves of the anatomy, withoutmajor tissue deformation or penetration.

While the emphasis of this discussion is on retention of the pannus forchild birthing, it is noted that the present tissue retention system hasapplication in displacing or maintaining adipose tissue of other bodyregions for many different medical applications, only some of which arediscussed herein. As alternative use and variation is shown in U.S.patent application Ser. No. 11/743,858, filed May 3, 2007, titled“Apparatus and Method of Inhibiting Perianal Tissue Damage” isincorporated herein in its entirety.

Turning now to FIGS. 1a and 1b , the tissue retention system, referencedherein by the numeral 100, includes an anchor pad 102 and a tensionmember 104. As discussed in greater detail below, the anchor pad 102 isconfigured to attach directly to a patient's skin, such as adjacentadipose tissue, and the tension member 104 releasably attaches to theanchor pad to maintain the anchor pad 102 and the attached skin in aposition that provides visualization or access to a body region for amedical procedure.

The anchor pad 102 includes a pad body 106 and an attachment surface108. A biocompatible adhesive layer 107 is disposed on the pad boy 106and is configured to adhere directly to a patient's skin or an inanimatesurface. In some embodiments, the adhesive of the adhesive layer 107 isconfigured to easily release from the patient's skin with minimal damageor soreness after a medical procedure is complete. In some embodiments,prior to use, the adhesive layer 107 faces a non-stick backing (notshown) that can be peeled away to reveal the adhesive layer 107 on thepad body 106. In one embodiment, the anchor pad 102 is formed of amaterial known as Gamma Stable Hook Fastener with Adhesive with aproduct number of 7333 sold by 3M of St. Paul, Minn. Examples ofsuitable adhesives include, without limitation, acrylic adhesives,silicone based adhesives, urethane adhesives, synthetic or naturalrubber adhesives, among others.

The attachment surface 108 is configured to face away from the patient'sskin and provides an interfacing surface to releasably fasten to thetension member 104. The attachment surface 108 includes a releasablefastening feature, that may be, for example, a part of a hook and loopfastening system or a releasably adhesive system. While hook and loopfastening systems are disclosed as being used in the illustratedembodiments, it is contemplated that in further embodiments alternativereleasable fastening mechanisms are employed. For example, suchreleasable fastening systems have a greater shear strength than peelstrength and may include, but without limitation to alternativestructures, magnetic couplings, specialized adhesives, ratchet teeth,and directional specific fibers. In the exemplary embodiment shown, thefastening feature comprises hooks 109 of a relatively rigid hook portionof the hook and loop fastening system. As shown in FIG. 1a , thefastening feature is included over substantially the entire attachmentsurface 108 of the anchor pad 102 as a plurality of hooks 109.

In one embodiment, the anchor pad 102 is at least partially flexible andconforms to contours of a patient's body shape. For example, the pad 102is sufficiently flexible to conform about a patient's curved abdominalapron or along a patient's curved thigh. It may have the rectangularshape shown, or may have other alternative shapes, such as circular,crescent, oval, triangular, or any other suitable shape. In theexemplary embodiment shown, the anchor pad 102 includes rounded cornersthat enable the anchor pad 102 to more comfortably adhere to thepatient's skin and are less likely to cause irritation. In the exemplaryembodiment shown, the anchor pad 102 includes a width W_(p) and a lengthL_(p) with the width W_(p) being greater than the length L_(p). In someembodiments, the width W_(p) is in the range of 5-14 inches long and thelength L_(p) is in the range of 4-8 inches long. In other embodiments,the width W_(p) is in the range of 7-8 inches long and the length L_(p)is in the range of 5-6 inches long. Thus, in some aspects, the anchorpad 102 has an area ranging from 20 to 112 square inches. Otherdimensions, both larger and smaller, are also contemplated.

The adhesive used to form the adhesive layer 107 is selected to havematerial properties permitting it to be peeled from the patient's skinafter the procedure is complete by pulling a corner or edge from theskin at an angle from the skin within a range from about 10 to 170degrees without damaging the skin. In addition, the anchor pad 102 andadhesive can be removed without damaging the skin without the use ofwater, soap, solvent or other releasing material. In some embodiments,the adhesive is selected to have an adhesion to LDPE, 180 Degree peel of15-50 oz/inch width, and more particularly, about 20-50 oz/inch width,and more particularly, about 30-40 oz/inch width, and even moreparticularly, about 35-37 oz/inch width. The adhesive may be askin-friendly, rubber based adhesive. Further, both the anchor pad 102and the tension member 104 are latex free. Further, the adhesive isconfigured so that in some embodiments, less than 10% of the adhesiveforming the adhesive layer remains on the skin as residue. In otherembodiments, less than 5% of the adhesive forming the adhesive layerremains on the skin as residue.

The tension member 104 includes a flexible outer material 105, a bodyportion 111, and an attachment surface 110 with a fastening featureformed thereon. Here the fastening feature is a plurality of generallysoft fiber loops 113. In one embodiment, the fastening feature isincluded over substantially the entire attachment surface 110 of thetension member 104. In one aspect, the body portion 111 with the fiberloop attachment surface 110 is a material known as Gamma Stable Loopwith Adhesive with a product number of 7331 sold by 3M of St. Paul,Minn. In one aspect, the flexible outer material 105 is a material knownas optiFLEX SELECT® manufactured by FLEXcon. In some embodiments, theouter material 105 is formed of a polyethylene material, and the bodyportion 111 is formed of a nylon material.

In some embodiments, the tension member is non-distensible. Accordingly,in these embodiments, the tension member is substantiallynon-distensible in its longitudinal direction and flexible in at leastone axis deviating from the longitudinal axis. In other embodimentshowever, the tension member is distensible. Accordingly, in theseembodiments, the tension member is at least partially distensible in itslongitudinal direction and also flexible in at least one axis deviatingfrom the longitudinal axis. In some embodiments, the materials formingthe tension member are selected so that the tension member yields morethan 20% of its length under tension loads up to 60 force pounds. Insome embodiments, it yields more than 10% of its length under tensionloads up to 60 force pounds. In other embodiments, it yields more than2% of its length under tension loads up to 60 force pounds. In someembodiments however, the tension member does not yield, but elasticallydeforms to increase length under load and return to its original lengthwhen the load is removed. It should be noted that the tension member mayinclude substantially homogonous or substantially uniform materialproperties along its length.

Material properties and structure of the tension member 104 determineits yield strength or elasticity. For example, the width, thickness, andmaterial of the outer material 105, (in combination with the otherlayers of the tension member 104) may be selected to provide desiredyield and elasticity characteristics. Furthermore, these may be selectedto cooperate with the adhesive and size of the anchor pad 102 so that,in use, the tension member 104 stretches before the anchor pad 102begins to detach from the patient's skin. In the following descriptions,the hook and loop fastener is designed to hold the described shear loadwithout failure. For example only, in embodiments where the anchor pad102 has adhesive properties such that it begins to detach from thepatient's skin at peel loads of three oz/inch width at 180 degree peel,then the tension member 104 may be designed to elongate eitherelastically or in-elastically at loads less than three oz/inch widthapplied at 180 degrees. Accordingly, in embodiments having a pad widthof 5 inches, loads of 15 oz at 180 degrees are required to peel theanchor pad at 180 degrees. This example however, is not limiting as itis contemplated that other levels of adhesion also may be implemented.In some embodiments, an additional safety factor may be included, suchthat the outer material 105 (or the entire tension member 104) begins tostretch at, for example, loads less than 90% of the peel load. In otherwords, using the example above, the safety factor may be applied so thatthe outer material 105 begins to stretch at loads less than 90% of 15 ozat 180 degree peel or equivalently 13.5 oz. The safety factor may be80%, 60%, or other factor between 0% and 100%.

In other embodiments, the tension member 104 elongates eitherelastically or in-elastically before the anchor pad 102 begins to damagethe patient's skin, thereby avoiding blistering, delamination, or otherdamage that may occur by inadvertent overloading. As an example, if skindamage occurs under shear loads of 40 oz/in² of skin and the anchor pad102 has an area of 12 in², then the tension member 104 may be formed sothat the outer material 105 (or the entire tension member 104) stretchesat loads less than 480 oz or equivalently at loads less than 30 lb. Insome embodiments, an additional safety factor may be included, such thatthe outer material 105 (or the entire tension member 104) begins tostretch at, for example, loads less than 90% of the anchor pad areamultiplied by the skin shear force. In other words, using the exampleabove, the safety factor may be applied so that the outer material 105begins to stretch at loads less than 90% of 12 in² multiplied by 40lbs/in^(t), equaling 432 oz or equivalently 27 lb. The safety factor maybe 80%, 60%, or other factor between 0% and 100%. It is noted that theuse of skin damage occurring at 40 oz/in^(t) is merely an exemplaryvalue, and skin damage may begin occur at loads much higher or muchlower. The load value at which skin damage occurs may vary depending onthe age of the patient, the location of the anchor pad on the body, theangle of the force applied, the amount of time the force is applied, thedwell time of the adhesive, skin properties such as porosity andmoistness, and other factors. It is contemplated that the tension membermay have properties that permit it to elastically or in-elasticallyelongate at loads of about 60 lbs in some embodiments. Elongation isconsidered to have occurred when the tension member stretches more than2% of the length between anchoring points. In some embodiments, thetension member elongates at loads of about 40 lbs, while in otherembodiments, at loads of about 30 lbs. In yet other embodiments, itelongates at loads of about 20 lbs. Further embodiments have propertiesthat permit elongation at about 10 lbs. Other force amounts, smaller andgreater than those identified also may be used. It should be noted thatthe tension member may include substantially homogonous or substantiallyuniform material properties along its length between the anchoringpoints. In other embodiments, minor interruptions in uniform propertiesalso are contemplated.

In some embodiments, the outer material 105 is adhesively bonded to thebody material 111 through a rolling process to form an integratedtension member 104, as shown in FIGS. 1a and 1b . In these embodiments,the yield strength or elasticity of the outer material 105 and the bodymaterial 111 together, or likewise, the entire tension member 104 may bearranged so that, in use, the tension member 104 elastically orin-elastically stretches before the anchor pad begins to slip or damagethe patient's skin, as discussed above.

In some embodiments, the tension member is designed to carry tensionloads, but to not carry compression loads. Accordingly, it can be foldedor rolled for packaging, and then unfolded or unrolled for use, havingproperties as a non-distensible or distensible fabric material of thedescribed structure.

The tension member 104 has a width W_(s) and a length L_(s) with thewidth W_(s) being less than the length L_(s). In some embodiments, thewidth W_(s) of the tension member 104 is sized within a range of 1 and 5inches. In other embodiments, the width W_(s) is within a range of 2-4inches, and in yet other embodiments, the width W_(s) is about 3 inches.The length L_(s) is considerably longer than the width W_(s) to enablethe tension member to extend from the anchor pad 102 as shown in FIG. 1bto a second anchoring location either on the patient or on some otherstructure, as discussed below. In some embodiments, the width to lengthratio of the tension member 104 is between the range of 1:5 to 1:50.Other ratios outside this range also are contemplated.

The tension member length L_(s) is greater than its width W_(s) and isused with the anchor pad 102 to maintain displaced adipose tissue in aless-obtrusive position during a medical procedure. The fasteningfeature on the attachment surface 110 interfaces with the fasteningfeature on the attachment surface 108 of the anchor pad 102. Asdescribed above, in the exemplary embodiment shown, the fasteningfeature of the tension member 104 is the loop of a hook and loopfastening system. Accordingly, the loop portion of the tension member104 selectively attaches to the hook portion on the anchor pad 102. Insome embodiments, the fastening feature covers the entire surface of thetension member 104. This enables simple attachment without considerationfor whether the tension member is too large or small for any givenpatient.

In the embodiment shown, the hooks 109 on the attachment surface 108 ofthe anchor pad 102 face away from a patient's skin and the loops 113 onthe attachment surface 110 of the tension member 104 that face toward apatient's skin. Thus, only the softer loop portion of the fasteningsystem directly contacts the patient's skin. This may avoid somediscomfort that may occur if the hook portion of the fastening systemwere placed against the patient's skin. In other embodiments however,the loops are disposed on the anchor pad and the hooks are disposed onthe tension member.

Referring to FIG. 1a , the width W_(s) of the tension member 104 isshown as less than the width W_(p) of the anchor pad 102. In someembodiments, the ratio of the width W_(p) of the anchor pad 102 to thewidth W_(s) of the tension member 104 is within a range of 1.5:1 to 4:1.In some embodiments, the ratio of the width W_(p) of the anchor pad 102to the width W_(s) of the tension member 104 is within a range of 2:1 to3.5:1. Other ratios, both larger and smaller than those identified herealso are contemplated.

The anchor pad 102 and tension member 104 together define an overlaparea represented by the area of the tension member 104 that isselectively fastened to the anchor pad 102. FIG. 1a shows this overlaparea having a length Lo which is the maximum length of the tensionmember 104 fastened to the anchor pad 102 and having an overlap width Wowhich is the maximum width of the tension member 104 fastened to theanchor pad 102. In FIG. 1a , the overlap length Lo and the overlap widthWo are substantially the same as the respective anchor pad length L_(p)and the tension member width Ws. However, the overlap area may differfrom that shown and is dependent upon where the tension member 104 isplaced on the anchor pad 102. Furthermore, it is contemplated that inalternative embodiments, the width of the fiber loops 113 is less thanthe width of the tension member 104. Thus, in these embodiments, theoverlap area (defined as the area of the tension member that isselectively fastened to the anchor pad) is less than the area of thetension member that overlies, but does not fasten to, the anchor pad102. In some embodiments, the ratio of anchor pad area to overlap areais within a range of 1:1 to 6:1. In other embodiments, the ratio iswithin a range of 1.5:1 to 5:1, and in yet other embodiments, the ratiois within a range of 2:1 and 4:1.

In some embodiments, the tension member 104 and the anchor pad 102 areselected so that when fastened together, they have a 135 degree closurepeel strength average within a range of about 1-10 oz/inch width andmore particularly, within a range of about 1-8 oz/inch width, and moreparticularly about 2-6 oz/inch width. In other embodiments, they areselected to have a 135 degree closure peel strength average within arange of about 3 oz/inch width. It is contemplated that in high tensionapplications of one embodiment, the 135 degree closure peel strength isapproximately 32 oz/inch width. In a preferred embodiment, the adhesiveto skin peel strength is greater than the closure peel strength. Forexample, in one aspect, the skin peel strength is at least twice asgreat as the closure peel strength. In a further embodiment, the hookand loop closure peel strength is less than 50%, and preferably lessthan 25%, of the adhesive to LDPE, 180 Degree peel of the anchor padadhesive. Still further, the shear strength of the hook and loopfastening system described herein is substantially greater than theclosure peel strength. For example, the shear force applied to thetension member/anchor pad overlap area described above can be as high as80 pounds while the hook and loop closure peal strength at 135 degreesis less than 10 oz/inch width. Thus, in one aspect, the force needed todecouple the hook and loop fastening assembly is less than 20 oz. whilethe shear strength to hold tissue is at least as large as 80 pounds.

The tension member 104 has a length L_(s) long enough to extend from apatient's abdominal region, around the patient's shoulder or neck andback to the abdominal region. In some embodiments, the tension member104 has a length long enough to extend from the patient's abdominalregion to an area above the patient's head to attach to a stablestructure, such as a surgical bed. The anchor pad 102 and the tensionmember 104 may be formed of a non-radiopaque material permitting it tobe used without affecting radiology processes or treatments. Stillfurther, in one aspect, the tension member 104 is generally inelastic inits central longitudinal axis and flexible in at least one axisdeviating from the central longitudinal axis.

In use, the anchor pad 102 attaches to the patient's skin in an areaadjacent to loose or adipose body tissue. The tension member 104attaches to and extends from the anchor pad 102 in a direction that theadipose tissue is to be displaced. It may be anchored on a second anchorpad securely disposed for such a purpose. For example, the second anchorpad may be disposed on the patient's body, such as along the patient'sshoulder, or may be anchored to a structure, such as a stable portion ofa surgical table. In some embodiments, the tension member 104 extendsabout the shoulder or neck of the patient and back to the first anchorpad 102 or one adjacent to it. By attaching the tension member at bothends in tension, displaced excess tissue may be maintained in a desiredposition. Furthermore, the tension member 104 may be attached andsecured in place before an incision is even made.

Because in the embodiment shown, the anchor pad 102 has a width greaterthan the width of the tension member 104 or attachment area of thetension member, the anchor pad 102 acts to laterally distribute loadingfrom the tension member 104 along an area of adipose tissue having agreater width than the overlap area. Further, because the attachmentsurface 108 of the anchor pad 102 includes the attachment features,which in the example shown are hooks 109 of a hook and loop fastener,the tension member 104 is disengaged from the anchor pad 102 andreattached with little effort in a different location on the anchor pad102, permitting easy tension member adjustment to an infinite number oflocations on the anchor pad 102. Naturally, this same adjustment to anyof an number of locations may be made on the tension member 104 and thesecond anchor pad disposed spaced apart from the anchor pad 102. Stillfurther, once the tension member 104 is engaged to pad 102, the attachedadipose tissue will be held in a desired location. Some examples of thetissue retention system in use will be described with reference to FIGS.2-9.

FIG. 2 shows an example of an obese patient lying on a hospital surgicaltable in a position for a surgical procedure, such as, for example, acesarean section. The procedure includes placing the patient on theoperating room table per protocol, generally in supine position with aleft lateral tilt. The arms may be secured using a loose tension memberon arm boards. As shown, the patient has a pannus or abdominal apronentirely covering the lower abdomen. In order to perform the procedure,the operating physician is required to expose the lower abdomen bydisplacing the pannus. The physician or other medical personnel may liftthe pannus and then scrub the abdomen per hospital policy with acleanser such as alcohol or Betadine scrub. It is contemplated, however,that in some instances, a part of or the entire pannus displacementprocedure, as described below, may occur prior to scrubbing or preppingthe pannus. The adhesive described above maintains its adhesion in thepresence of cleansers such as alcohol and Betadine scrub.

A backing material may be removed from an anchor pad 102 to expose theadhesive layer 107 (FIG. 1b ) of the anchor pad 102. The anchor pad 102is then be applied directly to the skin on the lower abdomen so that theadhesive 107 on the anchor pad 102 securely adheres it to the skin. Careshould be taken to not place the anchor pad 102 over skin intended forincision. In the example in FIG. 2, two anchor pads 102 a, 102 b havebeen applied to the underside of the pannus so that an upper portion,such as for example about a third of each anchor pad, protrudesoutwardly from the folds of skin. Also, in the example in FIG. 2, theanchor pads 102 a, 102 b are applied so that the width lies relativelyperpendicular to the direction that the adipose tissue is to bedisplaced. Additional anchor pads (not shown) may be placed atadditional locations on or about the patient. In some embodiments, theadditional anchor pads may be disposed on the patient's shoulders. Theseadditional anchor pads also serve to connect to the tension member 104as described below.

Turning now to FIG. 3a , in some embodiments, medical personnel manuallylift the pannus away to expose the lower abdomen where the cesareansection will be performed. In such situations, the medical personnelplace fingertips on the anchor pad 102 rather than on the bare skin todistribute point loads applied by fingers against the pannus, therebyreducing the chance of bruising. The medical personnel hold the pannusin place until the tension member 104 (see FIG. 3b ) is utilized.

FIG. 3b shows tension members 104 a, 104 b replacing the medicalpersonnel to maintain the pannus in a desired position. In theembodiment shown, one end of the tension member 104 a is attached to theanchor pad 102 a on the pannus while the other end of the tension member104 a is tensioned and attached to a second anchor pad (not shown)disposed on the patient's shoulders. Here, as discussed above, theanchor pad 102 a includes a hook material and the tension member 104 aincludes a loop material. As is apparent from FIG. 3b , a second tensionmember 104 b attaches in tension to the anchor pad 102 b and extends toa second anchor pad (not shown) disposed on the patient's shoulder. Thedashed line in FIG. 3b shows an exemplary location where the anchor pads102 may be placed to secure the pannus. However, it is contemplated thatthe anchor pads may be placed in regions outside the dashed line,including the supra pubic region of the body. The shaded area 302represents an area that is normally hidden where the skin of the pannusrests against the skin of the lower abdomen.

In some embodiments, the tension member 104 does not attach to anchorpads disposed on the patient's shoulders or other body portion, but mayextend behind the patient's neck or about the patient's shoulder andreturn to one of the anchor pads 102 a, 102 b disposed on the pannus.Thus, a single tension member may be used to secure the pannus. Forexample, referring to FIG. 3b , in such an embodiment, the tensionmember 104 a and 104 b are ends of a single tension member extendingbehind the patient's neck.

FIG. 3c shows the pannus displaced and maintained in position by thetension members 104 a 104 b, thereby exposing the lower abdomen for thesurgical procedure. Because the tension members 104 a, 104 b were placedin tension, the tension members 104 securely hold the anchor pads 102 inplace, and therefore, also holds the pannus in a specific position.

During or while still preparing to perform the medical procedure, thetension members 104 a, 104 b may be adjusted relative to the anchor pads102 a, 102 b. This is accomplished by simply manually supporting thepannus while detaching one of the tension members 104 a, 104 b from therelative anchor pad 102 a, 102 b, moving the pannus and/or the tensionmember to the desired position, and reattaching the tension member tothe anchor pad. In some embodiments, detaching the tension member fromthe anchor pad is simply accomplished by pulling the tension member todetach the attachment features, such as the hook and loop portions. Thetension member is then re-attached at the desired location. Adjustmentalso may be made by detaching the tension member 104 from the anchor pad(not shown) disposed on or about the patient's shoulder. In this way,the tension member may be detached from the anchor pad, and the pannuscan be adjusted simply by manipulating the tension member 104.

As shown for example in FIG. 3c , the anchor pad width is greater thanthe tension member width. Further, the anchor pads are disposed on thepatient with a longer end extending laterally and the direction of thetension member extending longitudinally along the patient andsubstantially transverse to the longitudinal axis of the anchor pad.This provides a maximum level of load distribution to the skin at thedisplacement site in the regions lateral to the tension member,providing minimal discomfort to the patient.

Once the adipose tissue is securely displaced to expose the surgicalsite, medical personnel perform the medical procedure. For example, inone exemplary procedure, such as a cesarean section, the initial stepsof pre-positioning the adipose tissue includes exposing the surgicalsite where the surgical procedure will be performed as explained above.The incision site is then prepared. An incision, such as a transverseincision, a midline incision, or other suitable incision, is made in thelower abdomen as shown by an opening 310 in FIG. 3c . In one aspect,after making the incision, one or more retractors 312 are positioned inthe incision. A blade of the retractor is inserted through the skin intothe incision to further enlarge the size of the opening 310 to thatillustrated in FIG. 3c and/or to retract fat, muscle, blood vessels, andother structures below the surface of the skin. A surgical assistant canhold the handle of the retractor to maintain retraction. The procedurecontinues with the baby being born through the opening 310. Anyretractors used during the procedure are removed from the incision. Insome applications, such as child birthing, the change in the patient'sabdominal size will naturally reduce the force on the tension members.However, if increased tension and/or a further reduction in tension isrequired, the force on tension members 104 a, 104 b may be modified bymomentarily disengaging the tension members from the anchor pads 102 a,102 b. The tension members 104 a, 104 b are then reattached to theanchor pads 102 a, 102 b in an alternative tensioning position whilefurther medical steps of the procedure are completed on the patient. Forexample, the placenta may be delivered through opening 310 while thetension members are in the alternative tensioning position. Eventually,the opening 310 is sutured closed. In a preferred method, once thesurgical procedure is complete, the tension members 104 a, 104 b arede-tensioned and the anchor pads 102 a, 102 b are removed from thepatient's skin.

Although described with reference to exposing the lower abdomen, itshould be apparent that a similar method may be used to expose the groinregion when access is required. This may be useful with some patientsfor hysterectomies and normal vaginal births of obese patients, forexample. Still further, the retention system may be used for long termtreatments to expose tissue 302 to speed healing and/or preventinfection.

Furthermore, although the method was described with medical personnelmanually displacing the pannus with their hands prior to attaching thetension members 104 a, 104 b, it should be apparent that in someembodiments, the tension members 104 a, 104 b may be attached to theanchor pads 102 a, 102 b on the pannus prior to manually lifting thepannus to the desired position. In these instances, medical personneltake one end of the tension member 104 and place it on the anchor pad102 by pressing firmly so they adhere together. Next, the medicalpersonnel pull the tension member 104 to displace the abdominal pannusas far back as desired for the procedure, and then secure the other endof the tension member 104 to the second set of anchor pads.

FIG. 4 shows one example of the tension members 104 a, 104 b being usedto connect to the pannus as described with reference to FIG. 3, butinstead of attaching to the body at the second end, the tension members104 a, 104 b are connected to adjacent structure. Here, additionalanchor pads 102 c, 102 d are attached to a rigid or stable structure,such as a surgical table and provide an anchoring support for thepannus. Adhering the anchor pads to the table effectively eliminates twoadhesive contact points on the patient. Other stable structures also maybe used. As discussed above, the anchor pads 102 a, 102 b provide anunlimited number of anchor locations for the tension member 104.Likewise, the anchor pads 102 c, 102 d also provide such anchor locationbenefits. Accordingly, the tension member is adjustable at both endswhere it is selectively coupled to an anchor pad joined to the patientor a fixed object. In an alternative embodiment not illustrated in thedrawings, the tension member 104 includes an anchor pad that is fixedlycoupled to one end. When it is intended for joining to the skin, theanchor pad fixedly joined to the tension member has a surface area andadhesive property similar to the anchor pads described above. If theanchor pad is intended for adhering to a fixed object, the area of thepad may be reduced and/or the adhesive strength may be increased. Withthe tension member having a fixed anchor pad on one end, the fixedanchor pad is fixed in a first location and the opposite end of thetension member is releasably coupled to a second anchor pad such asdescribed above. Thus, in this embodiment, the system is only adjustableat one end. In still a further aspect, tension member 104 b may bealternatively joined to anchor pad 102 a. The tension member 104 b maybe pulled toward anchor pad 102 d to further displace tissue near thedisplacement site at anchor pad 102 a in a second direction. Thus,anchor pad 102 a can be pulled toward anchor pad 102 c andsimultaneously pulled toward anchor pad 102 d. This combination givesthe user the ability to simultaneously mobilize adipose tissue near thedisplacement site in multiple directions to achieve the desireddisplacement.

FIG. 5 shows an alternative use of the tissue retention system 100.Here, a first anchor pad 102 a is attached to the underside of apatient's large breast to support the adipose tissue and maintain it ina desired position. This is useful for example, in applicationsrequiring surgical access or radiological tests. In some examples, thetissue retention system may be used for oncology purposes, includingradiation treatment. This may enable positioning of the patient's fleshin substantially the same place each time the patient receives radiationtreatment. In some instances, the breast may be displaced or otherwisesecured to provide access to or around the breast during surgery. Asshown in FIG. 5, the tension member 104 extends in tension between thefirst anchor pad 102 a and a second anchor pad 102 b—one attached to thepatient's skin adjacent the adipose tissue and the other attached to asupporting structure, such as the bed.

Also, the retention system may serve as a breast compression system forobtaining mammographic images. An anchor pad can be adhered to thebreast in the place of the plate 18 shown in U.S. Pat. No. 4,691,333incorporated herein in its entirety. The anchor pad can include one ormore radiopaque markers if desired to permit orientation. The tensionmember can then be applied to compress the breast for imaging and/orneedle localization.

FIG. 6 shows other alternative uses of the tissue retention system 100.In one use, a first anchor pad 102 a is attached to a patient's thigh inorder to move the adipose tissue to provide access for a medicalprocedure. This may provide better visualization during repair orsurgery of the groin, perineum, vaginal vault, or other areas needingbetter visualization under the adipose tissue. These applications mayinclude general urology procedures. The tissue retention system 100 alsocan facilitate access to the femoral region for all types ofcardiovascular procedures, ranging from angioplasty to using a Foleycatheterization and to any type of thoracic surgery that requirescatheterization of the femoral artery. In another use, the first anchorpad 102 a is attached to a patient's thigh adjacent the femoral arteryincision. A tension member is fix to the anchor pad 102 a as a pressurebandage to apply pressure to the femoral artery incision after a femoralcatheterization procedure. A sterile pad (not shown) may be placeddirectly over the femoral incision and the tension member can be appliedto the sterile pad to compressively hold it in place. The sterile padcan control bleeding and acts to intensify the compression to theincision applied by the tension member. In this example, as in theexample of FIG. 5 above, the tension member 104 extends in tensionbetween first and second anchor pads 102 a, 102 b—one attached to thepatient's skin adjacent the adipose tissue and the other attached to asupporting structure, such as the bed.

In the applications shown in FIGS. 5 and 6, the method may be similar tothat described with reference to FIGS. 2-4 in that a backing is peeledfrom a first anchor pad 102 a and the anchor pad is applied directlyagainst the skin adjacent the adipose tissue to be displaced. The secondanchor pad is disposed on the patient at an anchoring location oralternatively, on a support structure, such as the table or bed. Theadipose tissue is displaced by hand and secured in place using thesupport member or is displaced by the support member 104 and secured inplace. At any point, the support member may be simply adjusted to attachto another location on the anchor pad.

FIG. 7 shows another alternative use of the tissue retention system.Here, a first anchor pad 102 a is attached to a patient's right buttocksand a second anchor pad 102 b is attached to the patient's leftbuttocks. Third and fourth anchor pads 102 c, 102 d are attached tosupport structure, such as the bed or table. Tension members 104 a, 104b extend in opposing directions between the first and third anchor pads102 a, 102 c and between the second and fourth anchor pads 102 b, 102 dto displace the buttocks and expose the rectum. This may provide bettervisualization during, for example, hemorrhoid surgery or repair of theanus, among other procedures.

FIGS. 8-10 show additional alternative uses of the tissue retentionsystem. In these embodiments, the patient is placed in a supine positionas required by certain surgical procedures. In the examples shown, thepatient's torso is elevated higher than the patient's head. In so doinghowever, the weight of the pannus, which on some obese patients may bemore than one hundred pounds, may shift to at least partially lie on thepatient's lungs, rendering breathing difficult or impossible.

The tissue retention system disclosed herein however, may be used toalleviate some of the weight on the lungs by maintaining the adiposetissue, such as the pannus, in its more natural location. FIGS. 8 and 9show a first embodiment of such a method with FIG. 8 being a top viewand FIG. 9 being a side of patient in the supine position. FIG. 10 showsan alternative embodiment.

Referring to FIGS. 8-10, first and second anchor pads 102 a, 102 b areattached to a patient's adipose tissue roll above the pannus. Third andfourth anchor pads 102 c, 102 d are attached to support structure, suchas the bed or table. Tension members 104 a, 104 b extend in thedirection of the patient's feet to displace or maintain the adiposetissue in a desired position. FIG. 9, because of its view, shows thetissue retention system 100 on only one side of the patient. It iscontemplated that in some embodiments, the tissue retention system wouldinclude the additional anchor pads and tension members as shown in FIG.8.

In FIGS. 8 and 9, the tension members 104 a, 104 b are attached to sidesof the table and in FIG. 10, the tension members 104 a, 104 b areattached to an end of the table. Accordingly, the weight of the pannusis maintained in an area at least partially off the lungs permitting thepatient to continue to breathe more easily.

It is contemplated that the tissue retention system disclosed herein maybe robust enough to maintain displaced tissue that applies loading onthe retention system of, for example, more than 20 lbs. In some aspects,the system is robust enough to maintain displaced tissue weighing morethan 25 lbs, 30 lbs, 40 lbs, 50 lbs, 75 lbs, 100 lbs, and 150 lbs. Otheramounts, both larger and smaller are also contemplated.

It is noted that the tissue retention system may be used tosimultaneously displace adipose tissue from different parts of the body.For example, for a femoral catheterization procedure, medical personnelmay use the tissue retention system to displace the pannus and the thighin the manners discussed above. Once the tissue is maintained in adisplaced position, the femoral region may be cleansed and theprocedures performed, such as introducing a needle through the cleansedportion of the femoral region. In addition, it is contemplated that whenmultiple anchor pads are used, they may be different sizes dependingupon their purpose.

FIG. 11 shows the direction of exemplary loading of the tension member104 relative to the position of the anchor pad 102 when maintainingadipose tissue in a displaced position. Here, the tension member 104 isshown under a tension load identified by the force arrow 350. Acounteracting force identified by a force arrow 352 acts between theanchor pad 102 and adipose tissue on a patient, represented by thereference numeral 354. We note that the force arrow 352 may include atransverse component (not shown) that counters the tension load actingon the tension member 104. Here, the tension member 104 is shown loadedat an angle θ relative to the attachment surface 108 of the anchor pad102. In use, loading applied from the tension member 104, through theanchor pad 102 and skin, to the tissue 354 is at an angle less thannormal to the attachment surface 108. Accordingly, the range of loadingangles θ may fall within the range of about −75 to 75 degrees. A forceapplied at an angle θ of about 90 degrees or greater would separate thefastening surfaces of the tension member 104 and anchor pad 102. In someembodiments, the loading occurs at an angle θ within the range of about−60 to 60 degrees relative to the fastening surface of the anchor pad102. In other embodiments, the loading occurs at an angle θ within therange of about −45 to 45 degrees relative to the fastening surface ofthe anchor pad 102. Other angles also are contemplated. In someembodiments, when the anchor pad 102 is placed on a curved surface, thetension member 104 may apply a tension load at an angle θ within therange of about −60 to 60 degrees relative to a line tangent to thefastening surface of the anchor pad 102 at the location where the anchorpad 102 and the tension member 104 separate.

While the examples set forth herein primarily describe attaching theanchor pads directly to the skin, in some alternatives, the anchor padsattach to surgical drapes over an incision. Accordingly, in theseinstances, the anchor pads may not attach directly to the skin, butattach to the surgical drapes adhered to the skin.

In addition, the tissue retention system may be a part of a kit. Oneexample of a kit, referenced herein as 400 is shown in FIG. 12. Withreference to FIG. 12, the kit 400 is disposed in an envelope 402 andincludes a plurality of pads 102 and a single tension member 104 thatmay be cut to a desired length during use. In some examples, four pads102 may be provided with a single tension member 104. In other examples,four pads 102 may be provided with two or more tension members 104. Inyet other embodiments, the kit includes two anchor pads 102 and onetension member 104. In some embodiments, a second envelope (not shown)may be provided within the envelope 402 and may contain therein theanchor pads 102. This keeps the tension member and pads from attachingto each other during storage or shipping and provides easier access toan attending health care provider. Other configurations of the above arealso contemplated.

In some embodiments, the kit may be assembled for specific surgicalprocedures. For example, a child birthing kit may include one or moreanchor pads, one or more tension members, a cotton tip applicator, bulbsyringe, pads, gauze, suction tubing, cord clamp, and a Foley catheter.It also may include a drape, table cover, gowns, basins, bowls, laps,absorbent towels, disposal bags, mayo stand cover, Bovie, steriletowels, light handle covers, labels, marking pen, and drapes/pouch,among other items. The kit also may include these following items thatmay be used during the procedure: a drape, table cover, gowns, 2 basins,laps, 1 disposal bag, needle counter, 1 six inch cotton tip applicator,tray organizer, 1 bulb syringe, 1 mayo stand cover, 1 CSR, wrap×2, Bovie(cauterizing unit), 1 pitcher (1200 ml), sterile towels, 2 pads, 1 gauze18″×18″, 2 light handle covers, 4×4 raytex-10, 1 absorbent towel, 1 bluebowl, suction tubing, labels, 1-CSR poly-back, 2 #20 blades, cord clamp,marking pen, suction equipment, drapes/pouch, Foley catheter. In alsomay include the physician's preference for sutures, dressing, staples,JP drains. A discussion of an exemplary method and/or additional itemsthat may be included in the kit is provided in U.S. Pat. Nos. 4,880,418,5,676,672, and 6,102,924, all incorporated herein in their entirety byreference.

In another example, a femoral catheterization kit may include one ormore anchor pads, one or more tension members, a needle sized topuncture the patient's skin and enter the femoral artery, and a flexiblehollow tube such as a catheter for threading through the femoral artery.A discussion of an exemplary method and additional items that may beincluded in the kit is provided in U.S. Pat. No. 4,355,026, incorporatedherein in its entirety by reference.

In yet another example, a hysterectomy kit may include one or moreanchor pads, one or more tension members, pads, gauze, cotton tipapplicator, suction tubing, and a Foley catheter. It also may include adrape, table cover, a gown, a basin, a bowl, a lap, absorbent towels,disposal bags, mayo stand cover, Bovie, sterile towels, light handlecovers, labels, marking pen, drapes/pouch. The kit also may includethese following items that may be used during the procedure: a drape,table cover, gowns, 1 mayo stand cover, 2 light handle covers, suctionequipment, irrigation, Bovie (cauterizing unit), laps, 1 disposal bag,sponges, absorbent towels. Graspers & dissectors: atraumatic graspers,soft bowel clamps, Maryland dissectors, scissors, needle holders,bipolar forceps and cord, endoloop, tissue morecellator for largeuterus. Vaginal instrument table: single tooth tenaculum, Alis graspers,dilators, uterine manipulator, Cohen cannula, speculum, Foley catheter.If doing laparoscopic hysterectomy, the kit also may include 10 mm, 0degree laparoscope 3 sizes (2-3 mm, 5 mm, 10 mm), and trocars. It mayalso include the physician preference for suture, dressing, staples.Other kits and uses also are contemplated.

While providing many advantages over known systems, the tissue retentionsystem disclosed herein is particularly useful on obese patients becauseit may be effectively used without wrapping around a portion of thepatient. For example, it may be entirely applied and used withoutlifting of limbs, the head, the torso, or legs. It can be applied andused entirely from one side of the patient, such as the patient's frontside or the patient's back side.

Other advantages and benefit may include one or more of the following:

-   -   allows caretaker to move flesh without breaking sterile field.        After the pannus has been scrubbed and sterilized, it is not        preferable to have nurses with their hands on the patient's        Pannus. There is a greater possibility of contaminating the        sterile field. When the anchor pads are placed on the patient's        Pannus and the ends of the tension members are attached to pads        anchored on the table, the caregiver may adjust and move the        pannus by adjusting the tension members (without actually        touching the patient);    -   frees the hands of the anesthesiologist or nurse (oftentimes,        these individuals assist the physician in holding up the pannus        of obese patients);    -   unlike tape and adhesives, this method of securing and/or moving        flesh applies adhesive only to the Pannus, while the tension        member does not directly adhere to the patient's skin. With        tape, the entire contact area has adhesive. This is problematic        because a) it is a time consuming process to wrap tape around        someone's Pannus and secure it to their shoulders or around the        patient's neck, and b) when tape is used, the skin underneath        all the tape (not just the tape on the Pannus) now has adhesive        all over it (i.e. tape around the shoulders, neck, and sides);    -   eliminates the need for Benzoin spray as an adhesive;    -   quickly applied and removed;    -   unlike narrow tape, the anchor pads distribute loads across a        larger surface area (which is better on the patient's skin);    -   allows user to “reposition” anatomy; and    -   latex free and residue free (when you remove the pads from the        patient's skin, tape residue may be not left on the skin). It is        designed to maintain maximum sheer loads while supporting,        retaining. or moving large masses of tissue.

In addition to being useful for the procedures discussed above, thetissue retention system also may be used in Bariatric procedures. Suchprocedures may include the steps of, for example, adhering a firstanchor pad to the patient's skin adjacent the adipose tissue andadhering a second anchor pad at a second supporting location, such asfor example, on the patient or on the surgical table. The tension membermay be selectively fastened in tension to the two anchor pads in amanner that the adipose tissue is disposed in a displaced position. Forexample, it may be used to maintain tissue in a displaced position inprocedures such as: Laparoscopic Roux-En-Y Gastric Bypass, LaparoscopicVertical Banded Gastroplasty, Laparoscopic Adjustable Banding,Laparoscopic Bileopancreatic Diversion, Laparoscopic BPD & DuodenalSwitch, Standard Roux-En-Y Gastric Bypass, Distal Roux-En-Y GastricBypass, Other Gastric Bypass Procedures, Vertical Banded Gastroplasty,Silastic Ring Gastroplasty, Gastric Banding, Banded Gastric Bypass, andOther Gastric Restriction, Biliopancreatic Diversion, among otherBariatric procedures. It may be used with additional procedures,including, for example, Laparoscopic Adjustable Gastric BandingProcedure or Lap-Band procedures. During set-up, during the procedure,or afterward, the tension member may be optionally removed from one orboth of the anchor pads and adjusted in order to displace the adiposetissue to a different position. After the procedure, the tension membermay be removed from the anchor pads and the anchor pads may be removedfrom the patient's skin.

Applicants note that the procedures disclosed herein are merelyexemplary and that the systems and method disclosed herein may beutilized for numerous other medical processes and procedures. Althoughseveral selected embodiments have been illustrated and described indetail, it will be understood that they are exemplary, and that avariety of substitutions and alterations are possible without departingfrom the spirit and scope of the present invention, as defined by thefollowing claims.

We claim:
 1. A tissue retention apparatus, comprising: a first anchor pad region comprising a first adhesive surface, the first adhesive surface being configured to adhere to a region of a patient's skin without damaging the patient's skin; a second anchor pad region comprising a second adhesive surface configured to adhere to a location spaced apart from the region of the patient's skin; and a tension region comprising a proximal end fixedly coupled to the first anchor pad region and a distal end releasably connected to the second anchor pad region.
 2. The tissue retention apparatus of claim 1, wherein the tension region is structurally arranged to elongate before the first anchor pad region detaches from the patient's skin when under load.
 3. The tissue retention apparatus of claim 1, wherein the tension region comprises a tension region width less than an anchor pad width of the first anchor pad region.
 4. The tissue retention apparatus of claim 1, wherein the second anchor region is configured to attach to a stationary supporting object remote from a surgical site of the patient.
 5. The tissue retention apparatus of claim 1, wherein: the first adhesive surface comprises a peel load based on an adhesive peel load characteristic, the tension region is structurally arranged to elongate at a load less than the peel load of the first anchor pad region, and the tension region comprises an outer layer and an inner layer adhesively bonded to the outer layer.
 6. The tissue retention apparatus of claim 1, wherein: at least a portion of the distal end of the tension region is configured to selectively releasably attach to at least a portion of the second anchor pad region.
 7. The tissue retention apparatus of claim 1, further comprising a backing material removably adhered to the first adhesive surface.
 8. The tissue retention apparatus of claim 1, further comprising a backing material removably adhered to the second adhesive surface.
 9. The tissue retention apparatus of claim 1, wherein the releasable connection between the distal end of the tension region and the second anchor pad comprises hook and loop materials.
 10. The tissue retention apparatus of claim 1, wherein the tension region comprises non-radiopaque material.
 11. A tissue retention apparatus, comprising: a first anchor pad region comprising a first adhesive surface, the first adhesive surface being configured to adhere to a region of a patient's skin without damaging the patient's skin; a first backing material removably adhered to the first adhesive surface; a second anchor pad region comprising a second adhesive surface configured to adhere to a location spaced apart from the region of the patient's skin; a second backing material removably adhered to the second adhesive surface; and a tension region comprising a proximal end connected to the first anchor pad region and a distal end connected to the second anchor pad region.
 12. The tissue retention apparatus of claim 11, wherein the tension region comprises a tension region width less than an anchor pad width of the first anchor pad region.
 13. The tissue retention apparatus of claim 11, wherein the tension region is configured to elastically stretch as the tension region elongates.
 14. The tissue retention apparatus of claim 11, wherein: The first adhesive surface comprises a peel load based on an adhesive peel load characteristic, and the tension region is structurally arranged to elongate at a load less than the peel load of the flexible anchor pad region.
 15. The tissue retention apparatus of claim 11, wherein the proximal end of the tension region is fixedly coupled to the first anchor pad region.
 16. The tissue retention apparatus of claim 15, wherein the distal end of the tension region is releasably connected to the first anchor pad region. 